Device recall: DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Class II FDA enforcement event 80577. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Philips Medical Systems Gmbh, DMC started this device recall on 27 Jun 2018. The firm address in the FDA record is in Hamburg. FDA put the recall in Class II. FDA event 80577 has 28 product records. The first FDA enforcement report date is 29 Aug 2018. The record gives the status Terminated, with the termination date 30 Apr 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide; International to 66 countries
Recalling firm
Philips Medical Systems Gmbh, DMC, Hamburg, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
28 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2841-2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 | 2 units | Class II | Terminated | 29 Aug 2018 |
| Z-2842-2018 | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | 2 units | Class II | Terminated | 29 Aug 2018 |
| Z-2843-2018 | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | Class II | Terminated | 29 Aug 2018 | |
| Z-2844-2018 | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | Class II | Terminated | 29 Aug 2018 | |
| Z-2845-2018 | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | Class II | Terminated | 29 Aug 2018 | |
| Z-2846-2018 | BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 | Class II | Terminated | 29 Aug 2018 | |
| Z-2847-2018 | CombiDiagnost R90 (Stitching Patient Support) 709030 | Class II | Terminated | 29 Aug 2018 | |
| Z-2848-2018 | DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 | Class II | Terminated | 29 Aug 2018 | |
| Z-2849-2018 | DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 | Class II | Terminated | 29 Aug 2018 | |
| Z-2850-2018 | DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 | Class II | Terminated | 29 Aug 2018 | |
| Z-2851-2018 | DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 | Class II | Terminated | 29 Aug 2018 | |
| Z-2852-2018 | DigitalDiagnost 4.1 (Stitching Patient Support) 712225 | Class II | Terminated | 29 Aug 2018 | |
| Z-2853-2018 | DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 | Class II | Terminated | 29 Aug 2018 | |
| Z-2854-2018 | DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 | Class II | Terminated | 29 Aug 2018 | |
| Z-2855-2018 | DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 | Class II | Terminated | 29 Aug 2018 | |
| Z-2856-2018 | DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 | Class II | Terminated | 29 Aug 2018 | |
| Z-2857-2018 | DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 | Class II | Terminated | 29 Aug 2018 | |
| Z-2858-2018 | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | Class II | Terminated | 29 Aug 2018 | |
| Z-2859-2018 | DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 | Class II | Terminated | 29 Aug 2018 | |
| Z-2860-2018 | DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 | Class II | Terminated | 29 Aug 2018 | |
| Z-2861-2018 | DigitalDiagnost Release 3 (Stitching Patient Support) 712025 | Class II | Terminated | 29 Aug 2018 | |
| Z-2862-2018 | DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 | Class II | Terminated | 29 Aug 2018 | |
| Z-2863-2018 | DigitalDiagnost Single Detector (Stitching Patient Support) 712020 | Class II | Terminated | 29 Aug 2018 | |
| Z-2864-2018 | DigitalDiagnost Upgrades (Stitching Patient Support) 712083 | Class II | Terminated | 29 Aug 2018 | |
| Z-2865-2018 | DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 | Class II | Terminated | 29 Aug 2018 | |
| Z-2866-2018 | DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 | Class II | Terminated | 29 Aug 2018 | |
| Z-2867-2018 | EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 | Class II | Terminated | 29 Aug 2018 | |
| Z-2868-2018 | EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 | Class II | Terminated | 29 Aug 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 28Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Jul 2020 | CombiDiagnost R90 Software Version R1.0 and R1.1 | Device | Class II | 1 |
| 19 Dec 2019 | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, genera | Device | Class II | 2 |
| 7 Nov 2018 | Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System | Device | Class II | 1 |
| 19 Sep 2018 | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 7120 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2841-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 80577. https://recallregister.com/fda/ii/80577/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide; International to 66 countries
- What quantity of product is in FDA event 80577?
- The event has 28 product records. The first record gives this quantity:
2 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.